Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia
NCT ID: NCT00206128
Last Updated: 2013-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
454 participants
INTERVENTIONAL
2004-11-30
2006-02-28
Brief Summary
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PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Seroquel SR
Eligibility Criteria
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Inclusion Criteria
* Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
* Able to understand and comply with the requirements of the study, as judged by the investigator.
Exclusion Criteria
* Patients with substance abuse or dependence, as defined by DSM-IV, and not in full remission. A urine drug screen test will be performed. The investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
* Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the investigator.
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Seroquel Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Cerritos, California, United States
Research Site
Garden Grove, California, United States
Research Site
National City, California, United States
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Pasadena, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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North Miami, Florida, United States
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Atlanta, Georgia, United States
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Hoffman Estates, Illinois, United States
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New Orleans, Louisiana, United States
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Jackson, Mississippi, United States
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Clementon, New Jersey, United States
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Staten Island, New York, United States
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Austin, Texas, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
Research Site
QLD, , Australia
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Burgas, , Bulgaria
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Radnevo, , Bulgaria
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Varna, , Bulgaria
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Vancouver, British Columbia, Canada
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Aurora, Ontario, Canada
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Burlington, Ontario, Canada
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Mississauga, Ontario, Canada
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Orléans, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Prince Albert, Saskatchewan, Canada
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Põltsamaa, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Helsinki, , Finland
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Mikkeli, , Finland
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Turku, , Finland
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München, Bavaria, Germany
Research Site
Göttingen, Lower Saxony, Germany
Research Center
Aachen, North Rhine-Westphalia, Germany
Research Site
Aachen, North Rhine-Westphalia, Germany
Research Site
Jena, Thuringia, Germany
Research Site
Halle, , Germany
Research Site
Marburg, , Germany
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Budapest, , Hungary
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Debrecen, , Hungary
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Gyula, , Hungary
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Nagykálló, , Hungary
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Szeged, , Hungary
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Székesfehérvár, , Hungary
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Bologna, BO, Italy
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Cagliari, CA, Italy
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Città di Castello, PG, Italy
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Ellera Di Corciano, PG, Italy
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Torino, TO, Italy
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Bassano del Grappa, VI, Italy
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Quartu Sant'Elena, , Italy
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Riga, , Latvia
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Sigulda, , Latvia
Research Site
Ziegzdrai, Kaunas County, Lithuania
Research Site
Klapeda, , Lithuania
Research Site
Šiauliai, , Lithuania
Research Sitte
Vilnius, , Lithuania
Research Site
Jerez de la Frontera, Cádiz, Spain
Research Site
Alcobendas, Madrid, Spain
Research Site
Colmenar Viejo, Madrid, Spain
Research Site
Madrid, Madrid, Spain
Research Site
Móstoles, Madrid, Spain
Research Site
Villamartín, , Spain
Countries
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Other Identifiers
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D1444C00146
Identifier Type: -
Identifier Source: org_study_id
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